Drug exposure during pregnancy: Current understanding and approaches to measure maternal-fetal drug exposure
Prescription drug use is prevalent during pregnancy, yet there is limited knowledge about maternal-fetal safety and efficacy of this drug use because pregnant individuals have historically been excluded from clinical trials. Underrepresentation has resulted in a lack of data available to estimate or...
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Frontiers Media S.A.
2023-03-01
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Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2023.1111601/full |
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author | Rachel E. Hudson Torri D. Metz Robert M. Ward Autumn M. McKnite Elena Y. Enioutina Catherine M. Sherwin Kevin M. Watt Kathleen M. Job |
author_facet | Rachel E. Hudson Torri D. Metz Robert M. Ward Autumn M. McKnite Elena Y. Enioutina Catherine M. Sherwin Kevin M. Watt Kathleen M. Job |
author_sort | Rachel E. Hudson |
collection | DOAJ |
description | Prescription drug use is prevalent during pregnancy, yet there is limited knowledge about maternal-fetal safety and efficacy of this drug use because pregnant individuals have historically been excluded from clinical trials. Underrepresentation has resulted in a lack of data available to estimate or predict fetal drug exposure. Approaches to study fetal drug pharmacology are limited and must be evaluated for feasibility and accuracy. Anatomic and physiological changes throughout pregnancy fluctuate based on gestational age and can affect drug pharmacokinetics (PK) for both mother and fetus. Drug concentrations have been studied throughout different stages of gestation and at or following delivery in tissue and fluid biospecimens. Sampling amniotic fluid, umbilical cord blood, placental tissue, meconium, umbilical cord tissue, and neonatal hair present surrogate options to quantify and characterize fetal drug exposure. These sampling methods can be applied to all therapeutics including small molecule drugs, large molecule drugs, conjugated nanoparticles, and chemical exposures. Alternative approaches to determine PK have been explored, including physiologically based PK modeling, in vitro methods, and traditional animal models. These alternative approaches along with convenience sampling of tissue or fluid biospecimens can address challenges in studying maternal-fetal pharmacology. In this narrative review, we 1) present an overview of the current understanding of maternal-fetal drug exposure; 2) discuss biospecimen-guided sampling design and methods for measuring fetal drug concentrations throughout gestation; and 3) propose methods for advancing pharmacology research in the maternal-fetal population. |
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institution | Directory Open Access Journal |
issn | 1663-9812 |
language | English |
last_indexed | 2024-04-09T22:13:49Z |
publishDate | 2023-03-01 |
publisher | Frontiers Media S.A. |
record_format | Article |
series | Frontiers in Pharmacology |
spelling | doaj.art-56dfaa2dd7b64d4dac748c5a41cc25dc2023-03-23T06:02:28ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122023-03-011410.3389/fphar.2023.11116011111601Drug exposure during pregnancy: Current understanding and approaches to measure maternal-fetal drug exposureRachel E. Hudson0Torri D. Metz1Robert M. Ward2Autumn M. McKnite3Elena Y. Enioutina4Catherine M. Sherwin5Kevin M. Watt6Kathleen M. Job7Division of Clinical Pharmacology, Department of Pediatrics, School of Medicine, The University of Utah, Salt Lake City, UT, United StatesDivision of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, School of Medicine, The University of Utah, Salt Lake City, UT, United StatesDivision of Clinical Pharmacology, Department of Pediatrics, School of Medicine, The University of Utah, Salt Lake City, UT, United StatesDepartment of Pharmacology and Toxicology, College of Pharmacy, The University of Utah, Salt Lake City, UT, United StatesDivision of Clinical Pharmacology, Department of Pediatrics, School of Medicine, The University of Utah, Salt Lake City, UT, United StatesDepartment of Pediatrics, Boonshoft School of Medicine, Wright State University, Dayton, OH, United StatesDivision of Clinical Pharmacology, Department of Pediatrics, School of Medicine, The University of Utah, Salt Lake City, UT, United StatesDivision of Clinical Pharmacology, Department of Pediatrics, School of Medicine, The University of Utah, Salt Lake City, UT, United StatesPrescription drug use is prevalent during pregnancy, yet there is limited knowledge about maternal-fetal safety and efficacy of this drug use because pregnant individuals have historically been excluded from clinical trials. Underrepresentation has resulted in a lack of data available to estimate or predict fetal drug exposure. Approaches to study fetal drug pharmacology are limited and must be evaluated for feasibility and accuracy. Anatomic and physiological changes throughout pregnancy fluctuate based on gestational age and can affect drug pharmacokinetics (PK) for both mother and fetus. Drug concentrations have been studied throughout different stages of gestation and at or following delivery in tissue and fluid biospecimens. Sampling amniotic fluid, umbilical cord blood, placental tissue, meconium, umbilical cord tissue, and neonatal hair present surrogate options to quantify and characterize fetal drug exposure. These sampling methods can be applied to all therapeutics including small molecule drugs, large molecule drugs, conjugated nanoparticles, and chemical exposures. Alternative approaches to determine PK have been explored, including physiologically based PK modeling, in vitro methods, and traditional animal models. These alternative approaches along with convenience sampling of tissue or fluid biospecimens can address challenges in studying maternal-fetal pharmacology. In this narrative review, we 1) present an overview of the current understanding of maternal-fetal drug exposure; 2) discuss biospecimen-guided sampling design and methods for measuring fetal drug concentrations throughout gestation; and 3) propose methods for advancing pharmacology research in the maternal-fetal population.https://www.frontiersin.org/articles/10.3389/fphar.2023.1111601/fullmaternal-fetal pharmacologypregnancyfetal drug exposureprenatal testingpharmacokinetics |
spellingShingle | Rachel E. Hudson Torri D. Metz Robert M. Ward Autumn M. McKnite Elena Y. Enioutina Catherine M. Sherwin Kevin M. Watt Kathleen M. Job Drug exposure during pregnancy: Current understanding and approaches to measure maternal-fetal drug exposure Frontiers in Pharmacology maternal-fetal pharmacology pregnancy fetal drug exposure prenatal testing pharmacokinetics |
title | Drug exposure during pregnancy: Current understanding and approaches to measure maternal-fetal drug exposure |
title_full | Drug exposure during pregnancy: Current understanding and approaches to measure maternal-fetal drug exposure |
title_fullStr | Drug exposure during pregnancy: Current understanding and approaches to measure maternal-fetal drug exposure |
title_full_unstemmed | Drug exposure during pregnancy: Current understanding and approaches to measure maternal-fetal drug exposure |
title_short | Drug exposure during pregnancy: Current understanding and approaches to measure maternal-fetal drug exposure |
title_sort | drug exposure during pregnancy current understanding and approaches to measure maternal fetal drug exposure |
topic | maternal-fetal pharmacology pregnancy fetal drug exposure prenatal testing pharmacokinetics |
url | https://www.frontiersin.org/articles/10.3389/fphar.2023.1111601/full |
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